Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

NCT06507865 | Recruiting DMC FDA Device

• 1 other identifier: TGR 23-02TB
• Study Type: observational
• Target: 200
• Locations: 9 countries
• Sites: 20

Brief Summary

The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.

Conditions

Aneurysm; Dissection, Aortic; TAA Thoracoabdominal Aortic Aneurysm; Thoracic Aortic Aneurysm; Transection Aorta

Keywords

TEVAR; Aneurysm; Dissection; Aorta; Endovascular stent graft; Thoracic branch endoprosthesis

Outcome Measures

Primary Outcomes (14)

• Deployment Technical Success

  Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system. The absence of any additional corrective procedure related to the device, procedure, or withdrawal of the delivery system. Events will not include interventions at the access site(s), lumbar drains to address spinal cord ischemia, or additional interventions to address non-treatment areas.

  Time of Surgery

• Lesion-related Mortality

  Death related to the index endovascular procedure or following conversion to open repair and death related to a complication from a secondary procedure associated with the index lesion or registry device. Any death where the treated disease / index lesion or registry device caused or significantly contributed to the death, including lesion-rupture, aortic-related complications, disease progression involving the index lesion.

  Day 30 through Year 2

• Lesion Rupture (treated area)

  Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.

  Time of Surgery through Year 2

• Lesion Enlargement (treated area)

  An increase in maximum vessel (e.g., aorta or treated branch) diameter of \> 5 mm in the region encompassed by the initial lesion as compared to baseline using orthogonal (i.e., perpendicular to the centerline) measurements on CT / CTA scans.

  Time of Surgery through Year 2

• Endoleaks (Type I-V)

  Perfusion of a treated lesion identified through imaging analysis.

  Time of Surgery through Year 2

• Device Migration

  Longitudinal movement of all or part of the device for a distance ≥ 10 mm, as confirmed by CTA scan, relative to anatomical landmarks and device positioning at the first post-operative CTA scan.

  Time of Surgery through Year 2

• Loss of Aortic / Branch Patency

  No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.

  Time of Surgery through Year 2

• Stroke

  Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that either persists for \> 24 hours or until death or symptoms lasting \< 24 hours, with pathology or neuroimaging confirmation of CNS infarction.

  Time of Surgery through Year 2

• Paraplegia

  New onset spinal cord injury rendering a subject non-ambulatory.

  Time of surgery through Day 30

• Paraparesis

  New onset spinal cord injury causing a minor motor deficit of the lower extremities.

  Time of surgery through Day 30

• New Onset Renal Failure

  New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for \> 4 weeks.

  Time of surgery through Day 30

• Renal Function Deterioration

  New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.

  Time of surgery through Year 2

• Device Integrity Events

  wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis.

  Time of Surgery through Year 2

• Reintervention

  Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure. This may include surgical or interventional treatment for endoleaks, access site(s) complications, disease progression (including interventions to address issues related to non-treated area of the index lesion, such as bare stent implantation to address bowel ischemia associated with aortic dissection), spinal drains for Spinal Cord Injury (SCI) management, or conversion to open surgery.

  Time of Surgery through Year 2

Secondary Outcomes (7)

• Access-related Complications

  Time of Surgery through Year 2

• Transient Ischemic Attack (TIA)

  Time of Surgery through Year 2

• Life Threatening Bleed

  Time of Surgery through Year 2

• Upper Extremity Ischemia

  Time of Surgery through Year 2

• False Lumen Status - Treated Segment

  Time of Surgery through Year 2

Study Arms (1)

GORE® TAG® Thoracic Branch Endoprosthesis

Patients treated with the TBE Device

Device: GORE® TAG® Thoracic Branch Endoprosthesis

Interventions

GORE® TAG® Thoracic Branch Endoprosthesis DEVICE

Patients presenting with thoracic vascular disease that may benefit from the placement of TBE device. The target registry population is patients who are treated with TBE at participating sites. TBE treatment is qualified as receiving the TBE aortic component, at a minimum.

Also known as: TBE device

GORE® TAG® Thoracic Branch Endoprosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Registry participants are derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. The target registry population is patients who are treated with TBE at participating sites. Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry. The registry has been designed with broad eligibility criteria to optimize the visibility of overall registry device use. An integral requirement to the target subject population is that the decision to use a TBE product has been made prior to considering the patient for possible registry participation. The TBE registry population will be defined as a successful recipient of TBE at the end of the index procedure.

You may qualify if:

• Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements Patient has been or is intended to be treated with an eligible registry device Patient is age ≥ 18 years at time of informed consent signature.

You may not qualify if:

• Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (20)

Medizinische Universität Wien

Vienna, A-1090, Austria

RECRUITING

Rigshospitalet University Hospital

Copenhagen, 2100, Denmark

RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

SUSPENDED

University of Heidelberg

Heidelberg, 69120, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

NOT YET RECRUITING

Universitätsklinikum Münster

Münster, 48149, Germany

ACTIVE NOT RECRUITING

Evangelismos General Hospital

Athens, 106 76, Greece

RECRUITING

Laiko General hospital of Athens

Athens, 11527, Greece

ACTIVE NOT RECRUITING

Policlinico di Sant'Orsola

Bologna, 40138, Italy

ACTIVE NOT RECRUITING

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

RECRUITING

AOU Padova

Padua, 35128, Italy

NOT YET RECRUITING

Azienda Ospedaliera "G. Brotzu"

Selargius, 09047, Italy

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Radboud UMC

Nijmegen, 6525 GA, Netherlands

RECRUITING

Complejo Hospitalario Universitario de Vigo

Vigo, 36312, Spain

WITHDRAWN

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

ACTIVE NOT RECRUITING

Skane University Hospital

Malmo, 205 02, Sweden

ACTIVE NOT RECRUITING

St Thomas' Hospital

London, SE1 7EH, United Kingdom

NOT YET RECRUITING

St Mary's Hospital

London, W2 1NY, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Diseases; Aortic Aneurysm, Abdominal; Aortic Aneurysm

Central Study Contacts

Gabrielle Valle Diekmann

CONTACT

+49 (0)174 690 0619; gvalledi@wlgore.com

Daniele Frangioni

CONTACT

+393427736782; dfrangio@wlgore.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 18, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Sharing of IPD will not routinely be performed and is contingent on an assessment of the researcher's proposal for novelty or value in advancing educational, quality or medical practice objectives in use of this data.
• Access Criteria: See above

Locations

IT (5); ES (2); DK (1); DE (4); GR (2); AU (1); NL (2); SE (1); GB (2)